Zegerid OTC OMEPRAZOLE SODIUM BICARBONATE RILEY CONSUMER CARE LLC FDA Approved Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect.
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Substance Omeprazole
Route
ORAL
Applications
NDA022281

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each capsule) Purpose Omeprazole 20 mg Acid reducer Sodium Bicarbonate 1100 mg Allows absorption of this omeprazole product
Inactive Ingredients
Inactive Ingredients FD&C blue no. 1 FD&C blue no. 2 aluminum lake FD&C red no. 40 gelatin polysorbate 80 sodium lauryl sulfate sodium starch glycolate sodium stearyl fumarate titanium dioxide
Strengths
20 mg 1100 mg
Quantities
14 capsules
Treats Conditions
Use Treats Frequent Heartburn Occurs 2 Or More Days A Week Not Intended For Immediate Relief Of Heartburn This Drug May Take 1 To 4 Days For Full Effect
Pill Appearance
Shape: oval Color: white Imprint: ZEG

Identifiers & Packaging

Container Type UNKNOWN
UNII
KG60484QX9 8MDF5V39QO
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN Zegerid OTC works differently from other OTC heartburn products, such as antacids and other acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days. TIIPS FOR MANAGING HEARTBURN Do not lie flat or bend over after eating Do not eat late at night or just before bedtime Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables Eat slowly and do not eat big meals If you are overweight, lose weight If you smoke, quit smoking Raise the head of your bed Wear loose-fitting clothing around your stomach CLINICALLY PROVEN TO Treat Frequent Heartburn Zegerid OTC ® Omperazole 20mg / Acid Reducer Sodium Bicarbonate 1100mg /Allows Absorption of this Omperazole Product 14 CAPSULES One 14-Day Course of Treatment MAY TAKE 1 TO 14 DAYS FOR FULL EFFECT 24 HOUR 1H9D5 XL C1

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN Zegerid OTC works differently from other OTC heartburn products, such as antacids and other acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days. TIIPS FOR MANAGING HEARTBURN Do not lie flat or bend over after eating Do not eat late at night or just before bedtime Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some fruits and vegetables Eat slowly and do not eat big meals If you are overweight, lose weight If you smoke, quit smoking Raise the head of your bed Wear loose-fitting clothing around your stomach CLINICALLY PROVEN TO Treat Frequent Heartburn Zegerid OTC ® Omperazole 20mg / Acid Reducer Sodium Bicarbonate 1100mg /Allows Absorption of this Omperazole Product 14 CAPSULES One 14-Day Course of Treatment MAY TAKE 1 TO 14 DAYS FOR FULL EFFECT 24 HOUR 1H9D5 XL C1

Overview

Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect.

Indications & Usage

Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect.

Dosage & Administration

Directions for adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 capsule with a glass of water at least 1 hour before eating in the morning take every day for 14 days do not take more than 1 capsule a day do not chew or crush the capsule do not open capsule and sprinkle on food do not use for more than 14 days unless directed by your doctor Repeated 14-day Courses (if needed) you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor Heartburn in children may sometimes be caused by a serious condition.

Warnings & Precautions
Warnings Allergy alert: do not use if you are allergic to omeprazole. omeprazole may cause severe skin reactions Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away
Do Not Use

Do not use if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain These may be signs of a serious condition. See your doctor.

Stop Use & Ask a Doctor

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Storage & Handling

Other information each capsule contains: sodium 303 mg read the directions, warnings and accompanying label information before use store at 20°- 25°C (68°-77°F) tamper-evident: do not use if the blue band around the capsule is missing or broken. Do not use if foil inner seal imprinted with "Sealed for your protection" is missing, open or broken. keep product out of high heat and humidity protect product from moisture

Questions

Questions or comments? Call 1-888-4-ZEG-OTC (1-888-493-4682) between: 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday Zegerid OTC design logo is a registered trademark of Riley Consumer Care, LLC d/b/a Carlin Consumer Health Zegerid OTC is a registered trademark of Santarus, Inc. Dist by: Riley Consumer Care, LLC d/b/a Carlin Consumer Health New York, NY 10151


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